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Generated: January 20, 2019

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Details for New Drug Application (NDA): 061905

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NDA 061905 describes E.E.S. 400, which is a drug marketed by Arbor Pharms Llc and is included in two NDAs. It is available from one supplier. Additional details are available on the E.E.S. 400 profile page.

The generic ingredient in E.E.S. 400 is erythromycin ethylsuccinate. There are one hundred and three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the erythromycin ethylsuccinate profile page.
Summary for 061905
Tradename:E.E.S. 400
Applicant:Arbor Pharms Llc
Ingredient:erythromycin ethylsuccinate
Formulation / Manufacturing:see details
Pharmacology for NDA: 061905
Suppliers and Packaging for NDA: 061905
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
E.E.S. 400 erythromycin ethylsuccinate TABLET;ORAL 061905 ANDA Arbor Pharmaceuticals, Inc. 24338-100 24338-100-13 100 TABLET in 1 BOTTLE (24338-100-13)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 400MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 400MG BASE
Approval Date:Aug 12, 1982TE:BXRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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